Trials / Completed
CompletedNCT01484574
A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease
A Non-randomized, Open Label, Multicentric, Dose Ranging , Phase II Study Assessing the Efficacy and Safety of Intramuscular Administration of Stempeucel - CLI™ (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With Critical Limb Ischemia Due to Buerger's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Stempeutics Research Pvt Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Allogeneic Mesenchymal Stem Cells | Single intramuscular administration of low dose of stem cells |
| BIOLOGICAL | Allogeneic Mesenchymal Stem Cells | Single intramuscular administration of intermediate dose of stem cells |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2014-02-01
- Completion
- 2016-03-01
- First posted
- 2011-12-02
- Last updated
- 2016-09-13
Locations
10 sites across 1 country: India
Source: ClinicalTrials.gov record NCT01484574. Inclusion in this directory is not an endorsement.